Division of Bone Disease, Department of Rehabilitation and Geriatrics, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
Calcif Tissue Int. 2011 Aug;89(2):91-104. doi: 10.1007/s00223-011-9499-8. Epub 2011 Jun 3.
The pharmacological management of disease should involve consideration of the balance between the beneficial effects of treatment on outcome and the probability of adverse effects. The aim of this review is to explore the risk of adverse drug reactions and drug-drug interactions with treatments for postmenopausal osteoporosis. We reviewed evidence for adverse reactions from regulatory documents, randomized controlled trials, pharmacovigilance surveys, and case series. Bisphosphonates are associated with gastrointestinal effects, musculoskeletal pain, and acute-phase reactions, as well as, very rarely, atrial fibrillation, atypical fracture, delayed fracture healing, osteonecrosis of the jaw, hypersensitivity reactions, and renal impairment. Cutaneous effects and osteonecrosis of the jaw are of concern for denosumab (both very rare), though there are no pharmacovigilance data for this agent yet. The selective estrogen receptor modulators are associated with hot flushes, leg cramps, and, very rarely, venous thromboembolism and stroke. Strontium ranelate has been linked to hypersensitivity reactions and venous thromboembolism (both very rare) and teriparatide with headache, nausea, dizziness, and limb pain. The solidity of the evidence base depends on the frequency of the reaction, and causality is not always easy to establish for the very rare adverse reactions. Drug-drug interactions are rare. Osteoporosis treatments are generally safe and well tolerated, though they are associated with a few very rare serious adverse reactions. While these are a cause for concern, the risk should be weighed against the benefits of treatment itself, i.e., the prevention of osteoporotic fracture.
疾病的药物治疗管理应考虑治疗对预后的有益效果与发生不良反应概率之间的平衡。本综述旨在探讨与绝经后骨质疏松症治疗相关的药物不良反应和药物相互作用的风险。我们对来自监管文件、随机对照试验、药物警戒调查和病例系列研究的不良反应证据进行了综述。双膦酸盐与胃肠道效应、肌肉骨骼疼痛和急性期反应有关,极少数情况下还与房颤、非典型性骨折、骨折愈合延迟、颌骨骨坏死、过敏反应和肾功能损害有关。地舒单抗(均为极罕见)会引起皮肤效应和颌骨骨坏死,虽然目前还没有关于该药物的药物警戒数据。选择性雌激素受体调节剂与热潮红、腿部痉挛有关,极少数情况下与静脉血栓栓塞和中风有关。雷奈酸锶与过敏反应和静脉血栓栓塞(均为极罕见)有关,特立帕肽与头痛、恶心、头晕和肢体疼痛有关。证据基础的可靠性取决于反应的频率,对于非常罕见的不良反应,因果关系并不总是容易确定。药物相互作用很少见。骨质疏松症的治疗通常是安全且耐受良好的,但它们与一些非常罕见的严重不良反应有关。虽然这些反应令人担忧,但应权衡治疗本身的益处,即预防骨质疏松性骨折的风险。